Brand Name | ADVIA CENTAUR XPT RUBELLA G (RUB G) |
Type of Device | RUBELLA G IMMUNOASSAY, |
Manufacturer (Section D) |
SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
511 benedict avenue |
tarrytown NY 10591 5097 |
|
Manufacturer (Section G) |
SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
333 coney street |
|
east walpole MA 02032 |
|
Manufacturer Contact |
stacy
loukos
|
333 coney street |
east walpole, MA 02032
|
5086608576
|
|
MDR Report Key | 9338726 |
MDR Text Key | 220569357 |
Report Number | 1219913-2019-00237 |
Device Sequence Number | 1 |
Product Code |
LFX
|
UDI-Device Identifier | 00630414201412 |
UDI-Public | 00630414201412 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K003412 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional,user faci |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
11/18/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | N/A |
Device Catalogue Number | 10310283 |
Device Lot Number | UNKNOWN |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
10/24/2019
|
Initial Date FDA Received | 11/18/2019 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 04/05/2019 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Age | 26 YR |